BioCentury
ARTICLE | Regulation

Chirocaine's label

January 18, 1999 8:00 AM UTC

OXFORD - Following last week's FDA panel meeting, Chiroscience Group plc (LSE:CRO) intends to demonstrate that its long acting local anesthetic Chirocaine levobupivacaine is safer than existing products. Such a safety claim is considered essential to CRO's desire to capture a significant market share of the local anesthetic market, including capturing ground from Astra AB's competing products, bupivacaine and ropivacaine.

However, Chirocaine's future in the market will hinge on the outcome of the labeling issues that were not resolved at the meeting. A favorable outcome in negotiations with the agency would enable CRO to claim an improved safety profile over its racemic cousin bupivacaine...